5th BBBB Satellite Workshops
1. Workshop for Scientists in Academia, Pharmaceutical Industry, Regulatory Agencies, and Bioequivalence CROs
Burning Regulatory Issues in:
Bioequivalence, Regulations, Biowaivers, IVIVC, Biosimilars, Pharmaceutical Product Development, Continuous Process Verification, Bioanalytical Methods, GLP
Faculty of Pharmacy, National and Kapodistrian University of Athens
Date and Time:
Wednesday 25th of September 2013
09.00 – 18.00
Metropolitan Hotel, Athens, Greece
Address: 385, Syngrou Ave., 175 64, Athens, Greece
- Panos Macheras (Faculty of Pharmacy, National and Kapodistrian University of Athens)
- Michael Koupparis (Department of Chemistry, National and Kapodistrian University of Athens)
- Dimitrios Rekkas (Faculty of Pharmacy, National and Kapodistrian University of Athens)
- Vangelis Karalis (Faculty of Pharmacy, National and Kapodistrian University of Athens)
Industry, Regulatory Agencies, and CROs: € 300
Academia: € 200
Students: € 100
AFEA S.A. Travel & Congress Services
Professional Congress Organizer
Likavittou 39-41, 10672 Athens, Greece
Τel: (+30) 210 3668853
Fax: (+30) 210 3643511
This one-day workshop is intended for scientists, with or without prior experience, in Academia, pharmaceutical industry, regulatory agencies, and bioequivalence (BE) CROs. In this workshop we will discuss the scientific basis for the regulatory standards which have undergone rapid and significant changes since the beginning of this century up to the most recent changes in the regulatory framework, mainly in Europe.
The workshop will start with a detailed introduction to the current regulatory framework in Europe including the assessment of bioequivalence through the typical BE procedure or possible alternatives like “biowaivers” and “well-established use”. Special emphasis will be made on biowaivers in conjunction with concepts of the Biopharmaceutics Classification System (BCS) and more recent developments of the Biopharmaceutics Drug Disposition Classification System (BDDCS). Future trends will also be discussed. Furthermore, perspectives for new innovation trends such as ‘super-generics’ will be mentioned as well as considerations for non-biologic complex drugs and current opinions for regulatory pathways. In parallel, biotech and biosimilar products are the future wave of drug development; the relevant current or upcoming regulatory guidelines for biotech products and biosimilars will be discussed.
The workshop will proceed with discussions on unresolved or poorly explored issues in BE assessment such as the demonstration of BE in the case of highly variable drugs and the selection of clinical study designs for BE studies. In this context, different clinical designs will be discussed such as classic, replicate designs and the more recent two-stage designs. The European Medicines Agency (EMA) has suggested the use of two-stage designs for BE purposes; however, in the relevant EMA guidelines specific criteria are not fully defined. In this workshop, the methodology will be explained along with possible pitfalls. Finally, a roadmap for appropriate design of clinical studies, including classic, replicate, and various two-stage approaches will be analyzed and explained through realistic examples.
The meeting will also focus on current bioanalytical regulations as well as on the trends for good laboratory practice in the bioanalytical laboratory. In addition, this workshop will unveil issues such as:how manufacturers should operate, the use of modern pharmaceutical development concepts, quality risk management and quality systems at all stages of the manufacturing process. In this vein, the role of quality by design in pharmaceutical product development will be highlighted and the entire process from validation to verification will be analyzed.
Finally, the workshop will end with a demonstration of newly developed software intended for use in the pharmaceutical industry, CRO planning of bioequivalence studies, and academia. Among others, this software encompasses typical aspects of in vitro dissolution studies and pharmacokinetic analysis. Moreover, the software may be used to generate simulation data for all biopharmaceutically important drug studies e.g. dissolution, replicate BE studies, two stage designs in BE.
Overall, the workshop will focus on current hot topics of regulatory science as outlined in the attached program.
09.00: Welcome: P. Macheras
Morning session: Science and Regulation in Bioequivalence
09.15: P. Macheras. The Regulatory Framework in Europe: Bioequivalence, Biowaivers, Well-Established Use.
10.00: P. Macheras. From Generics to Super-Generics, Complex Drugs and Biosimilars.
10.45: Coffee Break
11.15: V. Karalis: Bioequivalence Assessment of Highly Variable Drugs – Replicate designs.
12.00: V. Karalis: In the Era of Two-Stage Designs: Why, When, How?
12.45: Lunch break
Afternoon session: Pharmaceutical Development and Bioanalytical Methods
13.45: D. Rekkas: Quality by Design in Pharmaceutical Product Development.
14.30:D. Rekkas: From Process Validation to Continuous Process Verification.
15.15: Coffee Break
15.45: M. Koupparis: Current Guidance for Bioanalytical Methods.
16.30: M. Koupparis: Good Laboratory Practice in the Bioanalytical Laboratory.
17.15: Coffee Break
Software Demonstration Session:
17.30: Modeling and Simulation in Pharmacokinetics and Bioequivalence – Analysis of Dissolution, Pharmacokinetic, and Bioequivalence data.
18.00: End of Workshop
9.00 am – 5.00 pm
Location: Metropolitan Hotel
Predicting oral drug bioavailability and its inter-individual variability: Interplay between formulation, drug permeability and metabolism using the Simcyp Advanced Dissolution, Absorption and Metabolism (ADAM) model
This event is part of Simcyp’s special series of workshops covering in-depth some of the major topics in model-based drug development. The course consists of lectures and hands-on practical sessions tutored by experts in the field. Delegates will learn about the modelling and simulation of:
• Gut wall permeability
• Drug solubility, dissolution and precipitation • Oral drug absorption incorporating food effects • Bioavailability and the impact of dosage form • Gut first-pass metabolism • Entero-hepatic recirculation • Inter-individual variability
The Simcyp Population-based Simulator and Simcyp Animal Simulators will be used throughout the workshops. Delegates will be guided through the hands-on exercises, so prior experience with the Simcyp Simulator is not a prerequisite for the course. Advanced Simcyp users will benefit from exploring the science and specific algorithms in more depth through discussions with tutors and peers.
Cost: Academics & Simcyp Consortium Member Companies £75 / Non Members £200.
For further information please contact Kelly Turton (firstname.lastname@example.org)
Please follow the link if you wish to register: http://www.simcyp.com/ProductServices/Workshops/International+BBBB+Conference/